More than one million women take meds while breastfeeding their babies each year, yet we know shockingly little about how those drugs may affect their milk and their infants. My two oldest children were just shy of their fourth and first birthdays when my husband and I moved to another city for work. Somewhere amid the chaos of securing a new place to live and a daycare, I managed to find a new ob-gyn. “I need reliable birth control,” I said to him, as we both eyed my son twirling the stirrups. He dashed off a prescription for oral contraceptives.
At the time, I was still nursing my youngest and wasn’t sure if the hormones would affect my baby or my milk supply. My doctor assured me they wouldn’t. But I didn’t really know or trust him yet; and as a health journalist, I had read conflicting information. I filled the prescription but decided not to start on the contraceptives until after my baby was weaned. In the interim, my husband and I depended on a somewhat less reliable birth control method — which turned out to be not so reliable at all. Nine months later, we welcomed child number three, a beautiful 9-pound baby boy, and leaned into the chaos just that much harder.
When you’re pregnant or breastfeeding for the better part of two or three years, the question of whether it’s O.K. to take a given medication is bound to arise. Four in five new mothers in the United States breastfeed their infants, according to the Centers for Disease Control and Prevention. And half of the mothers who breastfeed — an estimated 1.5 million women a year — will take medication.
Yet despite the fact that the number of women who breastfeed each year is rising, we have shockingly little solid evidence on how many of those drugs may affect breast milk and nursing infants, according to Dr Catherine Spong, M.D., chief of the division of maternal-fetal medicine at the University of Texas Southwestern Medical Center. Pregnant and nursing women are excluded from most clinical drug studies over fears of possible harms, said Dr Spong.
This, in effect, has led to a paradox: The people who need answers the most are often left out of the studies that could supply them.
The result is that some women forgo breastfeeding completely when taking medications, or decide not to take needed meds at all, said Dr Christina Chambers, PhD, a professor of paediatrics at the University of California, San Diego and president of the Organization of Teratology Information Specialists, a professional society that provides advice on medications during pregnancy and breastfeeding: “We hear these stories all the time.”
A Dearth Of Information
After Jessica Kornberg-Wall of Austin, Tex., delivered her daughter prematurely at 31 weeks, none of her doctors could tell her with certainty whether any of the three drugs she was on — a serotonin-norepinephrine reuptake inhibitor antidepressant, a blood pressure drug and a thyroid medication — would render her breast milk unsafe for her daughter. “She was 3 pounds and couldn’t even breathe on her own,” said Kornberg-Wall of her infant at birth. “I’m like, what am I putting in her body? Nobody had any answers for me. It was weird. It was frustrating.”
Jamie Erwin, a mother of two in Marietta, Ga., was similarly “frustrated” when her doctors told her that she’d need to stop nursing so that she could treat a stubborn urinary tract infection with a 60-day course of the antibiotic doxycycline. “There just wasn’t enough research done on it for them to say it was O.K.,” she said. If she took the antibiotic, her doctors said she’d have to bottle-feed her 6-month-old with formula and “pump and dump” for two months to maintain her milk supply — all while keeping up with her older 2-year-old. “I just didn’t know if I could do that,” said Erwin. “I was pretty disheartened.”
In 2017, Dr Spong chaired a task force which reviewed the available research on medication use during pregnancy and breastfeeding. Their results, published in 2018, found “limited information” for medications and pregnancy, said Dr Spong, and “far, far less for breastfeeding.” Of the 575 prescription drug and biological products the Food and Drug Administration approved for new labelling between 2015 and 2017, for instance, only 15 percent included information on breastfeeding. “It was quite remarkable to all of us participating in the task force, the dearth of information for lactating women,” said Dr Spong.
Both Dr Chambers and Dr Spong said that it’s neither difficult nor expensive to study women who are already taking medication, but that kind of research simply hasn’t been a priority. “The real travesty is that it’s a completely answerable question,” said Dr Chambers.
In April 2019, Dr Spong and a colleague published an editorial in The New England Journal of Medicine which pointed out that the problem, at least partially, stems from a lack of research funding. In 2017, for instance, the National Institutes of Health allocated $92 million — 0.3 percent of its budget — to research on breastfeeding. For comparison, the agency spent almost $6 billion on cancer research and $1.1 billion on diabetes research that same year.
While there’s no doubt that research on cancer and diabetes is important (they are the second and seventh leading causes of death and disability in the United States, respectively) — the more than 3 million American women who breastfeed every year need some research prioritization too, said Dr Spong. “Pregnancy and lactation are setting up mothers and babies for a long life of health,” she said. “That’s our future.”
What's Safe?
When studying drugs, researchers think of the human body as having different compartments: a brain compartment, a liver compartment and so on, according to Dr Thomas Hale, PhD, a professor of paediatrics at Texas Tech University Health Sciences Center and co-director of the InfantRisk Center, a leading research facility for medication safety during pregnancy and breastfeeding. “Nature really figured out how to make the breast milk compartment safe — isolated somewhat from the rest of the body — with the primary intent of safeguarding the baby,” said Dr Hale.
While experts have evaluated fewer than 400 of the thousands of medications available on the market for safety for use during breastfeeding, experts know enough about how the human body processes them to postulate how much may get into breast milk and potentially affect the baby. For most medications, according to available research, less than 3 percent of a mother’s dose of a drug can make it into her breast milk. “It’s likely that the vast majority of drugs are perfectly fine to use in breastfeeding if the dose is moderate,” said Dr Hale.
But some drugs require more caution than others.
In most cases, medications that are already proven safe for babies — such as acetaminophen (Tylenol), ibuprofen (Advil) or certain antibiotics like amoxicillin — are safe to take while nursing. Same goes for topical medications, said Dr Hale, such as benzoyl peroxide to treat acne or a steroid cream to quell a rash. Little or none of those drugs absorb into the bloodstream and therefore can’t transfer into breast milk.
There are fewer drugs in the unsafe category. Some of the most concerning ones, according to Dr Hale, are those that might cause serious side effects at their recommended dosages such as chemotherapy or certain radioactive drugs.
Some sedatives — including the anti-anxiety drugs alprazolam (Xanax) or diazepam (Valium); the anti-nausea drug promethazine (Phenergan); and prescription sleep aids — should be used with caution since they can cause excessive drowsiness and breathing problems in infants. If your infant is prone to apnea (brief episodes where the baby stops breathing) avoid sedating medications altogether, said Dr Hale.
While high-dose opioids are sedating and can pose risks to the baby, most women can safely take lower-dose opioids for up to three days if needed for pain after delivery, said Dr Hale
It’s also a good idea to avoid over-the-counter allergy, cold and sleep medications that contain antihistamines that can cause drowsiness — such as chlorpheniramine (Advil Allergy Sinus), diphenhydramine (Benadryl Allergy and Vick’s ZzzQuil) and doxylamine (Unisom). If you need allergy relief, the non-sedating antihistamines cetirizine (Zyrtec), loratadine (Claritin) and fexofenadine (Allegra) are a better choice.
As for birth control, the American Academy of Pediatrics currently says that all hormonal contraceptives are safe for the baby. However, those containing estrogen — such as combination birth control pills (Loestrin, Seasonique or Yaz), vaginal rings (NuvaRing) or birth control patches (Xulane) — might reduce milk supply. Progestin-only birth control pills (or so-called “mini-pills,” like Camila or Micronor) are least likely to interfere with breastfeeding. The A.A.P. advises nursing women who want to use any type of hormonal contraceptive to wait until breastfeeding is firmly established at six weeks.
Finally, Dr Spong advised against taking herbal products marketed to improve milk supply, such as fenugreek, milk thistle or others. “There’s no good evidence to show they work,” she said. And because they aren’t regulated by the F.D.A. as stringently as medications are, you can’t assume that a product actually contains what’s on the label.
Drug reactions are rare, but call your doctor if you notice signs that a medication is affecting your baby, such as excessive sleepiness, inconsolable crying, diarrhoea or rashes.
Filling The Gaps
After Kornberg-Wall received conflicting advice from her health care providers, she wound up performing her own medical research in the library. “We had to make these decisions — you know, me and my husband as first-time parents — having no idea what we’re doing,” she said.
Erwin, on the other hand, took to the online forum Reddit in desperation, hoping to at least find support for transitioning her daughter to formula while treating her U.T.I. Surprisingly, she also got solid medical advice. A fellow Redditor suggested that a six-day course of the antibiotic azithromycin might be an acceptable alternative to the two months of doxycycline her doctor had originally recommended. Erwin’s urologist agreed, though she still discouraged breastfeeding while taking it. However, her paediatrician gave her the O.K., noting that the drug is prescribed to infants.
The whole experience was “shocking,” said Erwin. “I don’t have a medical degree or a pharmacology degree, and yet I had to do my own research.”
“Unfortunately, many physicians — even obstetricians and paediatricians — don’t receive much education on the use of medications in breastfeeding,” said Dr Hale.
However, several online resources can help. MotherToBaby.org, sponsored by the nonprofit Organization of Teratology Information Specialists, and InfantRisk.com, maintained by the Texas Tech University Health Sciences Center, both have toll-free hotlines that provide complimentary expert advice. The Texas Tech research team has also created mobile apps that provide information on medication ingredients and safety during pregnancy and breastfeeding. And the N.I.H. maintains a website and free mobile app, which summarize the known effects of certain medications in pregnancy and breastfeeding.
As for filling in the research gaps, “I feel encouraged,” said Dr Chambers. U.C.S.D., where she is director of the Human Milk Research Biorepository, is involved in a multi-centre pilot study that is assessing how safe 10 older drugs — such as certain antibiotics, antidepressants and blood pressure medications — are for use during breastfeeding. “The hope is that if this demonstration goes well, the project can be expanded to more products and really move the field forward,” said Dr Chambers.
Meanwhile, both Dr Chambers and Dr Hale are conducting studies that analyze breast milk from nursing mothers who are taking certain medications to see how much of those drugs pass into their milk. (If you are a nursing mom who would like to contribute to research, check with Mommy’s Milk or the InfantRisk Center for information on how to participate.)
In the end, despite the uncertainty, both Erwin and Kornberg-Wall opted to continue breastfeeding while taking their meds. Kornberg-Wall said that she and her husband decided that the many benefits of nursing her daughter, now a thriving toddler, outweighed any potential risks of a small exposure to the drugs.
“I made the decision as best I could at the time with the information I could find, and so far she’s doing great,” Kornberg-Wall said.
"Is It Safe to Take That Medication While Breastfeeding?" by Teresa Carr © 2020 The New York Times Company
Teresa Carr is an award-winning journalist based in Texas who specializes in science and health. She is a former Consumer Reports editor and writer, a 2018 Knight Science Journalism Fellow at the Massachusetts Institute of Technology, and she pens the Matters of Fact column for Undark.
This story was originally published on 26 March 2020 in NYT Parenting.